Kornimate/medical-research-clean huggingface dataset:
effect of pf-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare

Conditions: Healthy

Summary: the purpose of this study is to examine the effect of pf-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.


Eligibility criteria:
inclusion criteria: * healthy male caucasian subjects with skin type i-iii inclusive (fitzpatrick scale), between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * an informed consent document signed and dated by the subject. * subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms. * subjects who demonstrate a capsaicin -mediated neurogenic flare with a value \>200 on the arbitrary laser doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at screening. exclusion criteria: * evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms. * history of febrile illness within 5 days prior to dosing.
invasive ventilation for neonates with acute respiratory distress syndrome(ards)

Conditions: Acute Respiratory Distress Syndrome; Conventional Mechanical Ventilation; High Frequency Oscillation Ventilation

Summary: acute respiratory distress syndrome (ards) in neonates has been defined in 2017.the death rate is over 50%. hfov and cmv are two main invasive ventilation strategies. however, which one is better needing to be further elucidated.

severe acute respiratory distress syndrome (ards) is one of the serious complications in critically ill neonates. it can result in severe hypoxemia refractory to mechanical ventilation. usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ards. and extracorporeal membrane oxygenation is used to neonates with severe ards. however, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. the purpose of the present study was to compare hfov with cmv as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ards.

Eligibility criteria:
inclusion criteria: * gestational age (ga) between 26+0 and 32+0 weeks; * birth weight less than 2000g; * assisted with cmv within 12 h after birth; * diagnosis with ards and/or rds; * stabilization before randomization within 12 h after birth: fio2\ 7.20, paco2\<=60 mmhg, paw \<=7-8 cmh2o; 90%-95% of spo2 exclusion criteria: * neonates who only needed noninvasive ventilation; * major congenital anomalies or chromosomal abnormalities; * neuromuscular diseases; * upper respiratory tract abnormalities; * need for surgery known before the first extubation; * grade ⅲ-iv-intraventricular hemorrhage (ivh); * congenital lung diseases or malformations or pulmonary hypoplasia.
recommendations for the treatment of children with acute lymphoblastic leukemia in the gfaop

Conditions: Childhood ALL

Summary: the lalgfa2019 recommendations redefine the standard risk criteria and propose to introduce anthracycline induction in so-called high-risk forms (lal line t and lal line b with leukocytosis greater than or equal to 50 g/l or in children less than 1 year of age or more than 10 years of age) as well as endoxan and methotrexate in high dose consolidation.

a few studies conducted in developing countries confirm that it is possible to significantly improve the prognosis of children with acute lymphoblastic leukemia (all) provided that the centres can benefit from a precise and adapted protocol and logistical support. the gfaop has been working with units for the past 20 years and this is the second study put in place by the group for the treatment of lal. the initial study was a feasibility study with the treatment of standard risk lal. this study gfalal2019 aims to include both standard and high-risk forms of lal. with this study it is hoped to: 1. ensure the feasibility of these recommendations. 2. to show that the correct application of the therapeutic recommendations will result in a complete remission rate (cr) close to 85% at the end of the induction treatment. 3. the survival without relapse of patients in rc will be close to 65% at 5 years.

Eligibility criteria:
inclusion criteria: children 0 to 18 all first diagnosis no prior chemotherapy cytology fab l1 or l2 - exclusion criteria: all l3 (burkitt) all previously treated with chemotherapy trisomy 21
a multicenter, randomized, double-blind non-inferiority trial to evaluate the efficacy and safety of entelon®

Conditions: Diabetic Retinopathy

Summary: this was a multicentre, randomised, double-blind controlled study that compared the efficacy and safety of v. vinifera extract, calcium dobesilate (cd), and placebo in subjects with dme. patients made 6 clinic visits, namely the screening visit; baseline visit (t0); and follow-up visits at 3 (t3), 6 (t6), 9 (t9), and 12 (t12) months.

eligible patients were randomised to one of the three study groups in a 1:2:2 ratio (placebo:gspe:cd group). the randomization schedule was generated and prepared using cubeiwrs® solution (crscube inc., seoul, south korea, hq). randomization was performed using a complete randomization algorithm according to the order of the baseline visit. subjects took three tablets of a masked study medication three times daily for 12 months; the first dose was taken in the morning of the baseline visit (t0) after baseline assessments were performed, and the last dose was taken in the evening before the month 12 visit (t12). three daily oral doses of 50mg tablets of gspe (entelon®, hanlim pharm, seoul, south korea) were administered to patients in the gspe group. placebo tablets lacked gspe, but their appearance was identical to that of the study group tablets. commercially available 250mg cd tablets (doxium®, ilsung pharm, seoul, south korea) were used in this study. the identity of the masked study medications was concealed by storing the medications in individually sealed envelopes at the study sites.

Eligibility criteria:
inclusion criteria: * singing a written informed consent prior to selection * type 2 dm aged between 40 and 80 years * diabetes is well controlled with drugs for at least 3 months(hba1c ≤9%) * best-corrected visual acuity over 0.5(20/40) by using etdrs cisual acuity test * diabetic macular edema with hard exudates csmt ≤300µm exclusion criteria: * lase therapy or intravitreal injection(anti-vegf, steroid) intraocular surgery within 6 months of enrollment * concomitant macular disease (such as retinal vascular occlusion, choroidal neovascularization, epiretinal membrane, etc) * poor image of optical coherence tomography(signal strength under 50% of narmal value) * concomitant therapy(kallidinogenase, vaccinium myrtillus extract, sulodexide) * non-controlled hypertension(systolic pressure \>140mmhg or diastolic pressure \<90mmhg) * severe renal insufficiency(creatinine \>2.2mg/dl, or undergoing dialysis)

Keywords: diabetic retinopathy, hard exudates
anticoagulation medical home

Conditions: Venous Thromboembolism; Patient-Centered Care

Summary: the primary study goal is to improve the quality of care transitions for patients with new episodes of venous thromboembolism (vte). primary outcomes: to measure differences in the quality of care transition, as measured by the care transition measure (ctm)-15 in the investigators target population of patients with incident vte randomized to either a multicomponent, anticoagulation medical home intervention or usual care. secondary major outcomes: to measure the difference in recurrent vte, major hemorrhage, all-cause re-admissions, and mortality between the investigators intervention and comparison groups at 30 and 90 days in the investigators target population. secondary other outcomes: to measure patient knowledge, health-related quality of life, and time in the therapeutic range (ttr) for patients on warfarin in the investigators target population.


Eligibility criteria:
inclusion criteria: * hospital admission; * diagnosis of: * vte (first or subsequent episode); or * dvt of leg or pelvis or upper extremities or other site confirmed by ultrasound or ct scan; or * pe with a positive ct spiral exam, pulmonary arteriogram, ct angiogram, or high probability ventilation perfusion scan. * for whom it is anticipated the treating medical team will prescribe an oral anticoagulant upon hospital discharge. exclusion criteria: * not engaged in primary care (has not seen a primary care practitioner within the previous 18 months).
retrospective database studies

Conditions: All Patients Undergoing Infertility Treatment

Summary: data collection and comparison of relationships between patient demographics, stimulation protocols and outcomes, retrieval and transfer outcomes, number and quality of oocytes and embryos retrieved and transferred, pregnancy rates and pregnancy outcomes.

no patient treatment is associated with the study.

Eligibility criteria:
inclusion criteria: none exclusion criteria: none

Keywords: infertility ivf
addressing tetrachloroethylene exposure in an impacted community

Conditions: Vapors; Inhalation; Cancer; Volatile Organic Compounds

Summary: groundwater in martinsville, in, is contaminated by volatile organic compounds (vocs), tetrachloroethylene (pce) and trichloroethylene (tce). indoor air in some residential and commercial buildings is also contaminated with pce and tce. this study is being conducted to better understand the impact of low-level exposures to these compounds on community members' health. data collected in this study will be used to help the community identify a course of action.

martinsville, in, is a community of 11,000 people that overlays four groundwater contamination sites, including a u.s. environmental protection agency (epa)-designated superfund site. the total area of groundwater contamination is over 60 acres and lies within a single aquifer. the contaminates are chlorinated volatile organic compounds (vocs), primarily tetrachloroethylene (pce) and trichloroethylene (tce). these contaminants are thought to originate from several dry cleaning and metal degreasing operations. an activated carbon filtration system has been in operation since 2005 to remove pce and chlorinated vocs from the municipal water, which now meets epa drinking water standards. however, a recent report from the agency for toxic substances and disease registry concludes that people's health may be harmed by breathing indoor air contaminated via vapor intrusion, the migration of volatile compounds from contaminated groundwater and soil into buildings above. the long-term goal of this research is to understand how pce exposure in communities affects health and to empower community members' participation in environmental health decision-making. in this project researchers will work with the community of martinsville, in to: 1. determine the extent and exposure levels to the contaminants by measuring the contamination in residents and at their homes. 2. assess the community's concern and perceptions about the contamination and associated health risks. 3. study the impact of the contaminants on visual and neurocognitive functions. 4. compare cancer rates in martinsville to county and state rates. the above information will help researchers and community partners co-design a targeted educational campaign to reduce community members' exposure to the contaminants.

Eligibility criteria:
inclusion criteria: * residents of martinsville, indiana * 18 years or older

Keywords: tetrachloroethylene trichloroethylene pce tce community environmental contamination chlorinated volatile organic compounds
the physiological response to routine head and neck cancer surgery

Conditions: Head and Neck Cancer

Summary: the main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of head and neck cancer

this project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(natural killer and cytotoxic t cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.

Eligibility criteria:
inclusion criteria: * elective unilateral neck dissections (levels i-v) and/or hemithyroidectomy surgery. * royal marsden hospital patients with head and neck cancer - all histological sub-types. * capable of providing informed consent * age \>17 * american society of anaesthesiologists classification i-iii. exclusion criteria: * past history of ipsilateral neck dissection. * bilateral neck dissection * a recent course of systemic steroids (\< 3 months) * pregnancy * involvement in drug trials * on following medications: interleukins, interferons, immunosuppressants and long term opiates * recent synacthen test (within 48 hours) * emergency surgery * american society of anaesthesiologists classification iv-v.
the efficacy and safety of eob-mri guided microwave ablation for early hcc: a multicenter, prospective, observational study

Conditions: Early Hepatocellular Carcinoma

Summary: hcc is one of most common causes of cancer-related death in the world due to lately diagnosis by typical hallmarks which rely on completed arterialization. so it is important to earlier diagnose and treat hypovascular early hcc(ehcc). the aim of this study is to evaluate the efficacy and safety of microwave ablation for early hcc, also to explore the feasibility of eob-mri (gd-eob-dtpa enhanced mri) guided ablation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. patients with chronic liver disease who are at high/extremely high-risk of hepatocellular carcinoma; 3. eob-mri suggestive of confirmed or suspected ehcc (single lesion ≤ 2 cm or number of lesions ≤ 3 and maximum diameter ≤ 2 cm) 4. no previous history of hepatocellular carcinoma; 5. not receiving any anti-cancer treatment; 6. liver function child-push a or b. exclusion criteria: 1. presence of lymph nodes or distant metastases; 2. presence of liver metastases; 3. prior malignancy; 4. severe cardiopulmonary or renal dysfunction; 5. suffering from uncorrectable coagulation dysfunction (prothrombin time \> 25 seconds, prothrombin activity \< 40%, platelet count ≤ 50x10\^9/l); 6. severe infectious lesions in the area of the puncture needle tract.

Keywords: early hcc; microwave ablation; efficacy; safety
vascular and cognitive assessments in patients with breast cancer undergoing chemotherapy after surgery

Conditions: Cognitive/Functional Effects; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this clinical trial studies vascular and cognitive assessments in patients with breast cancer undergoing chemotherapy after surgery. learning about vascular and cognitive function may help plan treatment and improve the quality of life of breast cancer patients. transcranial doppler ultrasound (tcd) may help study the side effects of chemotherapy in breast cancer patients and allow doctors to plan better treatment

primary objectives: i. to assess the feasibility of enrolling women who are receiving adjuvant chemotherapy for breast cancer to a clinical trial with assessments of vascular function and cognition before and after adjuvant chemotherapy and to obtain pilot data on outcomes that will be used in future larger-scale trials. secondary objectives: i. evaluate the presence, duration, and severity of brain circulation changes identified with transcranial doppler ultrasound (tcd) after adjuvant chemotherapy for breast cancer. ii. assess the changes in flow-mediated dilation (fmd) and aortic dilation that occur after adjuvant chemotherapy for breast cancer. iii. assess for correlation between the presence of brain circulation and vascular changes and performance on neuropsychological testing and the functional assessment of cancer therapy-cognitive scale (fact-cog). outline: patients undergo tcd examination including bilateral evaluation of standard intracranial arterial segments including the m1 and m2 segments of the middle cerebral artery (mca), the anterior cerebral artery (aca) and posterior (pca) cerebral artery, via the transtemporal acoustic windows, the internal carotid artery (ica) siphon via transorbital approach, and the vertebral and basilar arteries (proximal, mid, and distal) via the suboccipital approach. patients also undergo magnetic resonance imaging (mri). all tests occur between 21 days after completion of surgery and up to 30 days prior to adjuvant chemotherapy and between 20-60 days after completion of adjuvant chemotherapy. after completion of study treatment, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed non-metastatic breast cancer; stages 1-3 are acceptable * patients must be candidates for either neoadjuvant or adjuvant chemotherapy for breast cancer * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients who have had prior systemic chemotherapy are not eligible for the study * patients who are scheduled to receive trastuzumab and/or bevacizumab are not eligible * patients who are on dialysis * women who are pregnant are not eligible due to unknown risks and potential harm to the unborn fetus * patients with metastatic breast cancer are not eligible
use of the contura™ catheter to deliver accelerated partial breast irradiation to "low-risk" breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this national, multi-site study is to determine the safety and effectiveness of the contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

the cancer center of irvine is one of the busiest centers in the united states for contura accelerated partial breast irradiation.

Eligibility criteria:
inclusion criteria: * able and willing to sign informed consent * age 50 or older at diagnosis * life expectancy greater than 10 years (excluding diagnosis of breast cancer) * surgical treatment of the breast must have been lumpectomy. the margins of the resected specimen must be histologically free of tumor (negative surgical margins per nsabp criteria) * on histologic examination, the tumor must be dcis and/or invasive breast carcinoma * for patients with invasive breast cancer, an axillary staging procedure must be performed \[either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative\] * the t stage must be tis, t1, or t2. if t2, the tumor must be less than or equal to 3.0 cm in maximum diameter * estrogen receptor positive tumor exclusion criteria: * age \< 50 at diagnosis (regardless of histology) * pregnant or breast-feeding * active collagen vascular disease * paget's disease of the breast * prior history of dcis or invasive breast cancer * prior breast or thoracic radiation therapy for any condition * multicentric carcinoma (dcis or invasive) * synchronous bilateral invasive or non-invasive breast cancer * surgical margins that cannot be microscopically assessed or that are positive * positive axillary node(s) * t stage of t2 with the tumor \> 3 cm in maximum diameter or a t stage of t3 or t4 * estrogen receptor negative tumor

Keywords: contura cancer accelerated partial breast irradiation
study on the effect of gw876008 on cerebral blood flow in irritable bowel syndrome (ibs) patients and healthy volunteers

Conditions: Irritable Colon; Irritable Bowel Syndrome (IBS)

Summary: this is a three-period crossover study to compare gw876008 and placebo to see if gw876008 will normalise blood flow responses after different emotional stimuli.


Eligibility criteria:
inclusion criteria: * the subject should not have been taking and medication for the treatment of ibs for 1 month prior to the study * negative serum pregnancy tests (serum a-hcg negative) at screening (visit 1), and negative urine pregnancy tests at visits 1, 2, 3 prior to study medication dose. * non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study). * normal electrocardiogram (subjects must have no clinically significant abnormalities on a 12-lead ecg at screen). exclusion criteria: * subjects who are pregnant or nursing. * current evidence, or history of (at any time in the past) of a biochemical or structural abnormality of the digestive tract. including (but not limited to): inflammatory bowel disease (crohn's disease or ulcerative colitis); functional dyspepsia; lactose intolerance, not on a stable diet; celiac disease * subjects who are taking nsaids on a regular basis or within 48 hours of a study day. * the subject has a positive pre-study urine drug/alcohol screen. * a positive pre-study hiv 1 / 2, hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of the start of the study.

Keywords: ibs fmri
evaluation of speech-in-noise performance in cochlear implant recipients with a cros device on the contralateral ear

Conditions: Hearing Loss, Sensorineural

Summary: speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. recent findings in hearing technology allow for people to either use a hearing aid or a contralateral routing of signal (cros) device on the non-implanted ear. differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods. this study intends to determine whether or not a cros device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.


Eligibility criteria:
inclusion criteria\*: * an advanced bionics cochlear implant recipient with at least 6 months of listening experience * low frequency pure tone audiometry (pta) exclusion criteria\*: * non-english speakers * additional inclusion and exclusion criteria apply

Keywords: cochlear implant hearing loss hearing aids hearing tests